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Pantoprazole sodium freeze-dried preparation for injection and preparation method thereof

A technology of pantoprazole sodium and freeze-dried preparations, which is applied in the field of western medicine preparations to achieve the effects of high stability, reduced adverse reactions of diarrhea, and good reconstitution effect

Active Publication Date: 2012-09-19
NANJING CHIA TAI TIANQING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The inventor unexpectedly finds that the freeze-dried preparation of pantoprazole sodium for injection not only solves the problem of preparation stability, but also reduces the adverse reaction of diarrhea existing in existing products

Method used

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  • Pantoprazole sodium freeze-dried preparation for injection and preparation method thereof
  • Pantoprazole sodium freeze-dried preparation for injection and preparation method thereof
  • Pantoprazole sodium freeze-dried preparation for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] The preparation of embodiment 1 pantoprazole sodium for injection

[0031] Prescription composition:

[0032]

[0033]

[0034] Preparation Process:

[0035] (1) Measure the water for injection of total volume 2500ml, when temperature drops below 40 ℃, add the glucose of recipe quantity, glycine successively, stir to dissolve; Add the pantoprazole sodium of recipe quantity while stirring then, stir to make its dissolution;

[0036] (2) Use 1mol / L sodium hydroxide solution to adjust the pH of the solution to 10.5-10.8, add water for injection to 3000ml, and stir well;

[0037] (3) Add 0.1% activated carbon for needles into the solution, stir and absorb for 15 minutes, filter for decarburization, use a 0.45 μm microporous membrane for coarse filtration, and use a 0.22 μm microporous membrane for fine filtration;

[0038] (4) Fill the medicinal solution under aseptic conditions, put it into a plate, and send it to a freeze dryer for freeze drying.

[0039] Among ...

Embodiment 2

[0040] The preparation of embodiment 2 injection pantoprazole sodium

[0041] Prescription composition:

[0042]

[0043] Preparation Process:

[0044] (1) measure the water for injection of total volume 2400ml, when temperature drops below 40 ℃, add the glucose of prescription quantity, glycine successively, stir to dissolve; Add the pantoprazole sodium of prescription quantity then while stirring, stir to make its dissolution;

[0045] (2) Use 1mol / L sodium hydroxide solution to adjust the pH of the solution to 10.5-10.8, add water for injection to 3000ml, and stir well;

[0046] (3) Add 0.1% activated carbon for needles into the solution, stir and absorb for 15 minutes, filter for decarburization, use a 0.45 μm microporous membrane for coarse filtration, and use a 0.22 μm microporous membrane for fine filtration;

[0047] (4) Fill the medicinal solution under aseptic conditions, put it into a plate, and send it to a freeze dryer for freeze drying.

[0048] Among them...

Embodiment 3

[0049] The preparation of embodiment 3 pantoprazole sodium for injection

[0050] Prescription composition:

[0051]

[0052] Preparation process: with embodiment 1.

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Abstract

The invention relates to a pantoprazole sodium freeze-dried preparation for injection and a preparation method thereof. The freeze-dried preparation is formed by preparing components containing the following parts by weight into liquor for freeze drying after dissolving into water for injection: 60 to 80 parts of pantoprazole sodium, 100 to 300 parts of glycocoll, 50 to 100 parts of glucose and aright amount of sodium hydroxide. According to the pantoprazole sodium freeze-dried preparation for the injection, which is disclosed by the invention, the problem of stability of a preparation is solved; and moreover, an adverse reaction existing in a traditional product is lowered.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing pantoprazole sodium, in particular to a freeze-dried preparation of pantoprazole sodium for injection and a preparation method thereof, belonging to the technical field of western medicine preparations. Background technique [0002] Pantoprazole sodium (Pantoprazole Sodium, PAN-Na) is the proton pump inhibitor following omeprazole and lansoprazole. + -K + / ATPase activity, thereby inhibiting the secretion of gastric acid, for the treatment of duodenal ulcer, gastric ulcer, acute gastric mucosal lesions, compound gastric ulcer and other acute upper gastrointestinal bleeding. [0003] Pantoprazole Sodium for Injection is currently produced and marketed by many pharmaceutical companies in China. Clinically, it is mainly dissolved in a special solvent and added to 0.9% sodium chloride injection for intravenous infusion. In addition, the bibliographical reports about pantoprazole sodium free...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4439A61K47/26A61P1/04
Inventor 袁红波蔡萧芳
Owner NANJING CHIA TAI TIANQING PHARMA
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